This communication is to inform you of important safety information for Prolia® (denosumab). There are reports from healthcare providers of potential confusion between UDENYCA® (pegfilgrastim-cbqv) and Prolia due to carton similarities. Adverse reactions resulting from patients who received UDENYCA instead of the intended medication, Prolia, have been reported. Amgen is distributing the following Dear HCP letter to alert healthcare providers involved in the administration of Prolia. Please consider posting this information to your website or circulating to your members as appropriate.
IMPORTANT DRUG WARNING
Subject: Potential Carton Labeling Confusion between
UDENYCA® (pegfilgrastim-cbqv) and Prolia® (denosumab)
Dear Health Care Provider:
The purpose of this letter is to inform you of important safety information for Prolia, a human monoclonal antibody inhibitor of RANKL. Prolia is approved for treating osteoporosis in postmenopausal women, increasing bone mass in men with osteoporosis and in patients undergoing hormone ablation in prostate or breast cancer, and treating glucocorticoid-induced osteoporosis (see also “About Prolia”)
Risk of Product Selection Errors
There is a risk of medication errors due to the potential carton labeling confusion between UDENYCA and Prolia. There are reports from health care providers of potential confusion between UDENYCA and Prolia due to aesthetic similarities between the carton labeling of these products, including:
• UDENYCA and Prolia carton labeling both present the proprietary name and statement of strength in the same green color.
• UDENYCA and Prolia carton labeling both have green horizontal bands across the top of the principal display panel.
The use of the same green font color and color scheme minimizes the differences between the UDENYCA and Prolia carton labeling and results in product confusion, which may lead to the wrong product being administered.
There have been reports of adverse reactions resulting from patients who received UDENYCA instead of the intended medication, Prolia. Additional reports described near misuse of UDENYCA instead of the intended medication, Prolia.
1. Pharmacy staff should be made aware of the similar carton appearance between UDENYCA and Prolia.
2. Encourage storage of UDENYCA and Prolia inventories in separate areas away from each other.
3. Prior to Prolia administration, please confirm the correct medication has been selected. Follow institutional protocol such as barcode verification, review of the label/name on the carton, and good documentation practices before dispensing and administering Prolia.
Action being taken by Amgen
Amgen is distributing this DHCP letter to alert health care providers involved in the administration of Prolia of this potential carton labeling confusion between UDENYCA and Prolia. Amgen is monitoring this risk and will continue to work in close coordination with the US FDA.
Prolia, manufactured by Amgen, is approved for the following indications per the Highlights in the Prescribing Information:
• Treatment of postmenopausal women with osteoporosis at high risk for fracture
• Treatment to increase bone mass in men with osteoporosis at high risk of fracture
• Treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
• Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
• Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
For more information on UDENYCA, manufactured by Coherus Biosciences, Inc. please refer to UDENYCA FDA approved Prescribing Information.
Reporting Adverse Events
Health care providers and patients are encouraged to report adverse events in patients taking Prolia to Amgen at 1-800-77-AMGEN (1-800-772-6436). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
You may also contact our medical information department at 1-800-77-AMGEN (1800-772-6436) if you have any questions about the information contained in this letter of the safe and effective use of Prolia. This letter is not intended as a complete description of the benefits and risks related to the use of Prolia. Please refer to the full Prescribing Information and Medication Guide.